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NCT02597933 · ClinicalTrials.gov registry record · Phase 3
A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 580
- Enrollment target
NCT02597933: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT02597933 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 580 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02597933, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 580 participants
- Enrollment target
Study Summary
Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as a double blind, randomised, placebo-controlled trial with primary efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with SSc-ILD.
Primary Outcome
Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test. For this endpoint reported means represent the adjusted rate.
Interventions
- DRUG Placebo
- DRUG Nintedanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 580 participants |
| Start Date | 2015-11-12 |
| Est. Completion | 2018-11-28 |
| Phase | Phase 3 |
What the finished NCT02597933 record still lists
NCT02597933 is an interventional study that assigns participants to a tested intervention. The registered 580 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02597933 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02597933 about?
NCT02597933 is a clinical study titled "A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis". Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-...
What is the current status of trial NCT02597933?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 580 participants. The study started on 2015-11-12. Estimated completion is 2018-11-28.
What interventions are being tested in trial NCT02597933?
The interventions under investigation include: Placebo (DRUG), Nintedanib (DRUG).
Who is sponsoring clinical trial NCT02597933?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02597933's enrollment target sits among peer trials
580 656th of 2000 higher than 1,342 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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